A Study in Adults With Cutaneous T-cell Lymphoma (CTCL) Retreated With Brentuximab Vedotin
Real-World Evidence Study on Brentuximab Vedotin Retreatment Outcomes of Cutaneous T-cell Lymphoma Patients
1 other identifier
observational
26
4 countries
11
Brief Summary
The main aim of this study is to describe how effective and safe the re-treatment of adults with cutaneous T-cell lymphoma (CTCL) with brentuximab vedotin is. Another aim is to describe treatment patterns of persons with CTCL who have received brentuximab vedotin again. No treatment will be provided during this study. Information already existing in the participants' medical charts will be reviewed and collected.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2024
Shorter than P25 for all trials
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2023
CompletedFirst Posted
Study publicly available on registry
June 2, 2023
CompletedStudy Start
First participant enrolled
February 8, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2024
CompletedDecember 4, 2024
December 1, 2024
9 months
May 24, 2023
December 2, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (24)
Objective Response Rate (ORR) After First BV Administration
Up to approximately 12 months
ORR After Re-Treatment
Up to approximately 12 months after BV retreatment
Progression Free Survival (PFS) After First BV Administration
Up to approximately 24 months
PFS After BV Re-Treatment
Up to approximately 24 months after BV retreatment
Time to Next Treatment (TTNT) After First BV Administration (Regardless of Type of Next Treatment, i.e., BV or non-BV)
Up to approximately 16 months
TTNT After BV Re-Treatment
Up to approximately 24 months after BV retreatment
Number of Participant With Grading of Motor Neuropathy During First BV Treatment
Up to approximately 12 months
Time to Improvement of Motor Neuropathy During/ Post First BV Treatment
Up to approximately 24 months
Time to Resolution of Motor Neuropathy During/ Post First BV Treatment
Up to approximately 24 months
Number of Participants With Grading of Motor Neuropathy During BV Re-Treatment
Up to approximately 12 months after BV retreatment
Time to Improvement of Motor Neuropathy During/ Post BV Re-Treatment
Up to approximately 16 months
Time to Resolution of Motor Neuropathy During/ Post BV Re-Treatment
Up to approximately 24 months
Number of Participants With Grading of Sensory Neuropathy During First BV Treatment
Up to approximately 12 months
Time to Improvement of Sensory Neuropathy During/ Post First BV Treatment
Up to approximately 24 months
Time to Resolution of Sensory Neuropathy During/ Post First BV Treatment
Up to approximately 24 months
Number of Participants With Grading of Sensory Neuropathy During BV Re-Treatment
Up to approximately 12 months
Time to Improvement of Sensory Neuropathy During/ Post BV Re-Treatment
Up to approximately 24 months
Time to Resolution of Sensory Neuropathy During/ Post BV Re-Treatment
Up to approximately 24 months
Number of Participants With Grading of Neutropenia During First BV Treatment
Up to approximately 12 months
Number of Participants With Grading of Neutropenia During BV Re-Treatment
Up to approximately 12 months
Number of Participants With Grading of Febrile Neutropenia During First BV Treatment
Up to approximately 24 months
Number of Participants With Grading of Febrile Neutropenia During BV Re-Treatment
Up to approximately 12 months
Number of Participants With Grading of Serious Infections During First BV Treatment
Up to approximately 12 months
Number of Participants With Grading of Serious Infections During BV Re-Treatment
Up to approximately 12 months
Secondary Outcomes (4)
Number of Participants With Cutaneous Lymphoma Co-Medications or Strategies Used to Treat CTCL Disease
Up to approximately 12 months
Amount of BV Dose
Up to approximately 12 months
Number of Cycles of BV Administered
Up to approximately 12 months
Time Interval Between BV Administration
Up to approximately 24 months
Study Arms (1)
Brentuximab Vedotin
Participants with CTCL who were retreated with BV after relapse will be observed retrospectively and the outcomes will be observed from June 2023 to September 2023.
Interventions
As this is an observational study, no intervention will be administered.
Eligibility Criteria
Participants diagnosed with CTCL who were retreated with BV after relapse in France, Germany, Spain, and Italy.
You may qualify if:
- Participant with a confirmed diagnosis of CTCL (including Mycosis fungoides (MF), Sézary syndrome (SS), Primary cutaneous CD30+ anaplastic large cell lymphoma (pcALCL) and others) who reached a complete response (CR), partial response (PR) or stable disease (SD) on a previous treatment with BV and whose disease relapsed
- Participant who was treated with BV in at least 2 lines of therapy, other treatments could have been administered in between
- Participant has received three or more cycles of BV in retreatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (11)
Hopital Saint Andre
Bordeaux, 33075, France
Hopital Saint Louis
Paris, 75010, France
CHU Roeun
Rouen, 76031, France
Universitätsmedizin Göttingen
Göttingen, 37075, Germany
Klinikum Ludwigshafen, Hautklinik
Ludwigshafen, 67063, Germany
Universitätsklinikum Würzburg
Würzburg, 97080, Germany
Ospedale Maggiore Policlinico
Milan, 20122, Italy
AZ OSP Citta' Della Salute (Torino)
Torino, 10126, Italy
Hospital Clinic, Barcelona
Barcelona, 08036, Spain
ICO Hospitalet, Barcelona
Barcelona, 08908, Spain
Hospital Son Espases
Palma, 07120, Spain
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2023
First Posted
June 2, 2023
Study Start
February 8, 2024
Primary Completion
October 31, 2024
Study Completion
October 31, 2024
Last Updated
December 4, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.